Rehabilitation Matters

The PreventDFU Project

The Prevent DFU project is an interesting effort in diabetic foot care just launched by a European consortium.  The trans-European investigators hope to introduce novel technology for prophylaxis. The technique will aim to increase blood flow in the legs whilst users sleep and this may lead to a reduction in the number of people that develop foot ulceration. As the researchers point out, they only need to reduce the incidence of ulceration in a small percentage of patients to make this approach worthwhile.  The underlying technology was developed by Norwegian company Otivio.

Diabetic foot problems represent a massive global health issue and a great deal of effort is being made to prevent or at least reduce the incidence of foot ulceration.  Once foot ulceration has occured, there is a signifcantly higher risk of repeated ulceration with a corresponding impact on rehabilitation costs and quality of life.

 

Saving Money & Pressure Sores

Is it just me, but I'm seeing problems that I thought we had dealt with years ago resurfacing all over again.  Back in the 1980's and 1990's decubitus ulcers (pressure sores) were a big problem for the health service - both in economic and in human terms.  It seems the problem hasn't gone away. 

An analysis (Dr Foster Hospital Guide) of deaths in English hospitals has found 19 NHS trusts have higher rates than would be expected.  And pressure sores are still reported as a significant problem.

In the UK, NHS and related agencies are rightly striving to be more efficient and effective in providing care and so it wasn't a complete surprise when we received a call from an agency relating to our own product offerings in this area.  The implication being "Do we really need to use your product ?"

Since 1996 we have offered the PRAFO (Pressure Relief Ankle Foot Orthosis) Orthosis range to the UK and parts of Europe - we founded our business on it and worked hard to show it's merits as an effective pressure relieving technology for the heels and ankle area of the foot.  The heel area is one of the "at risk" areas of the body for patients who are relatively immobile and perhaps nutritionally compromised or diabetic.  Looking back at an article I wrote in 1996

"It has been estimated that 3% to 5% of all hospital inpatients will develop pressure sores either just before, during or after admission. Several sub-populations are at higher risk and its likely that costs will climb in line with demographic trends which by 2025 will see 25% of the population over 65 years of age"

I dont know the latest ulcer incidence figures for the UK as a whole but I'm pretty sure they won't be much better than they were twenty years ago.  Dr Fosters Guide reports some 6000 patients with pressure sores whilst in hospital. Unfortunately they can't say whether there were all hospital acquired. In the Trusts with the highest rates some 3.5% of patients were recorded as having pressure sores.

They point out that patients with pressure sores spend on average of 20 days in hospital compared with 10 days for those without sores. This adds up to an additional cost of more than £20m per year.

When there is a need to cut costs it is important to recognise the “true opportunity cost” of a particular intervention.  There is a cost of Acting and a cost of NOT Acting.  This is certainly true of not successfully dealing with pressure sores by preventing them.

We have always tried to argue with clinicians who wondered whether they could save £150 by not buying our product to prevent a heel ulcer.  Sometimes looking at it cynically, it might appear tempting to take a risk.  Not using the product looks like a saving - until say one person in ten gets a heel ulcer and all of the cost savings were blown out of the water.

Many patients treated for sores will have initially been admitted to hospital for some other condition.  As a pressure sore further limits a patient’s mobility and extends, for example, the use of a specialised bed then that resource, and all associated services, cannot turn to treat new patients.  For illustration, consider that for each sacral pressure sore which is prevented it becomes possible to undertake 16 total hip replacements.  This clearly emphasises the need for prevention when tackling this problem.

The important point is that competent clinicians can look at a patient and determine their individual level of risk.  The risk factors are well known and you would think this would lead to rational treatment decisions.

My complaint is that all too often someone takes a short sighted view of the need to save one on budget but completely misses the bigger strategic picture.  It looks like you saved a £100 but actually the saving was made at he the expense of thousands on someone elses budget.

A few years ago we won a clinical effectiveness prize for a poster entitled “Clinical Experience of the Pressure Relief Ankle-Foot Orthosis (PRAFO)” at the Scottish AHP Clinical Effectiveness and Practice Development Conference. 

This work looked at a small number of very severe cases of diabetic foot ulcers.  One case in particular comes to mind (See left) because the individual refused amputation (not an unusual situation) despite the severe calcaneal ulcer shown here.  The bone is clearly visible as we look at the lower part of the heel area.

I'm sorry if this is a distressing picture but if it is any consolation, severe neuropathy meant that pain was minimal.

The best solution for this individual would have been amputation. It would have accelerated recovery and the return to a reasonable quality of life would have been a case of a few months.  Having refused amputation the clinical challenge is very great.

For this type of ulceration the first rule is

"It's not what you put on the wound but what you take off"

In other words medicine and lotions and potions are not sufficent to deal with this problem.  One essential factor to encourage wound heeling was total pressure relief at the heel.

Using one PRAFO Orthosis and a great deal of antibiotic, podiatry and general medical care the wound eventually healed after 160 weeks. 

(See below)

Although this is quite a remarkable result, there is a sting in the tale - the patient died shortly after this wound healed having spent virtually 3 years with either lengthy hospital stays or daily visits.

An interesting point for us was that the perception we had previously been meeting from clinicians and adminstrators was that our orthosis was expensive - and yet as this case showed, despite the tens of thousands spent on other types of care, non of this would have achieved healing without using the PRAFO.

It is difficult to make decisions relating to health and health services.  Almost inevitably there will be "losers."  However, the least we can expect is rational treatment decisions that are looking at the true opportunity cost that applies.

The health service is full of well-meaning people but competence is also key and competence doesn't always seem to be in the right places.

The Quest for Improved Footwear for Diabetics

You may not be aware that around the world, every 30 seconds, someone loses a limb due to the late complications of diabetes.  Foot complications have a massive impact on the person and the cost of care provision to society.  This is not just a problem for the so called developed world - it's a global problem that clinicians have been struggling with for years. I share some thoughts about this issue.

Clinic teams try to personalise care by providing management that matches the persons individual level of risk of foot ulceration.  Friction and shear within shoes or from something in contact with the feet can cause massive damage.  You see diabetes can lead to neuropathy which can mean that the affected person is unaware of the damaging effects of pressure and shear.  In addition, the body tissues shape, elasticity and response to stress becomes altered by the disease process.

The key of course is prevention - but this has proved quite difficult in practice for a number of reasons.  Clinic teams that have worked for over 20 years in this area had hoped to see a reduction in patients coming to their clinics, but actually the growth in patient numbers still continues.

In Scotland, a Foot Action Group has created some clinical guidelines based on concensus of the best management strategies - again based on risk.  The aim always being to prevent the patient from having any ulceration. Once ulceration has occured, there is a much greater risk of further breakdown because of the altered tissue mechanics of the healed ulcer - assuming that healing can take place.

The "traffic light system" developed in Scotland is shown here.  (CLICK image to Magnify) It's meant to be clear and easy to understand.

It's long been recognised that footwear - properly designed to prevent the mechanical stresses that lead to ulceration is the key.  

Prescription footwear is widely used - but poorly understood. It's sometimes blamed for foot problems but, when properly designed should be a primary tool for the prevention of diabetic foot problems.

One the one had clinicians often have a poor appreciation of tissue mechanics and how shoes are designed and manufactured.  On the other hand persons knowledgeable about the requirements for prescription foot wear are not exactly numerous.  To top it all, prescription footwear has a reputation for being ugly and unattractive - especially with custom made shoes that might have to accomodate a deformed and high risk foot.

The challenge for clinicians and footwear manufacturers is to provide footwear that protects the users feet as required by the prescription and yet are attractive. Can we provide attractive footwear that our patients will wear? Increasingly the answer is "Yes"

This video introduces the challenge of creating prescription footwear. 

I'm a Director of Klaveness Skofabrikk, a Norwegian shoe manufacturer well-known for their "High St" shoes in Scandinavia.  We are on a quest to raise the quality of shoes for medical applications and apart from simply meeting a prescription, we want to use our technology to delight wearers.

 

There is a sting in the tail.  As in many areas of health care, consumers may have to recognise that they have to invest more of their own funds in their own health care. The NHS would be hard pressed to supply all that is required.

Second Abstract for Diabetic Foot Symposium, Netherlands, May 2011

We submitted a second abstract for the 6th International Symposium on the Diabetic Foot to be held in 
Noordwijkerhout, The Netherlands on May 11-14, 2011.

The title - "Could Biomechanical screening prevent Charcot Neuroarthropathy?" by Derek Jones and William Munro

Here is an Abstract from the Abstract..

Charcot Neuroarthropathy presents a particular challenge to the clinic team; constituting a progressive, often rapid deterioration of the weight bearing joints of the foot and ankle. It has for some time been acknowledged that neuropathy, which is a predisposing requirement for Charcot, is a problem of mechanics and not just medicine. Using a risk stratification tool which seeks to determine the level of risk to the foot from diabetic foot complications it is possible to identify patients at an earlier stage in the foot disease process and take prophylactic action.

This paper outlines a hypothesis linking repetitive biomechanical strain in the functional joints of the fore, mid and hind foot with atrophic and hypertrophic changes, leading to bony and ligamentous destruction as described by Fryburg and Saunders and classified by Eichenholtz. This Hypothesis implies that biomechanical factors may allow the foot at risk of Charcot deterioration to be recognised at an earlier stage, to enable appropriate orthotic management to be initiated.

Acknowledgement of the two main theories of pathogenesis (neuro-traumatic and neurovascular) supports the low grade repetitive strain placed on the functional joints of the foot. This in turn changes as the level of neuropathy increases and the subtle changes in connective tissue become more apparent, leading to changes in the biomechanical range of motion of the joints. There is speculation that there may be differences in the progression of Charcot neuroarthropathy in patients with type 1 and type 2 diabetes. These changes may hold the key to both drug and mechanical prophylaxis.

Treatment options and potential screening techniques will be discussed offering the opportunity to test the hypothesis.

Abstract for Diabetic Foot Symposium, Netherlands, May 2011

We submitted an abstract for the 6th International Symposium on the Diabetic Foot to be held in 
Noordwijkerhout, The Netherlands on May 11-14, 2011.

The title - "Advances in Footwear Prescription and Manufacturing Technology for Low Risk Patients" by Derek Jones, William Munro and Bjorn Klaveness.

Here is an Abstract from the Abstract..

Since Edmonds et al back in 1986 demonstrated the importance of a specialised foot clinic we have eagerly awaited a reduction in the number of patients that present with ulceration.  Instead of this clinic lists have grown.  Preserving and protecting the foot whilst patients are at low to moderate risk is vital.  This implies the wide availability of appropriate, cost-effective, shoes that patients are willing to wear.

Shoes are vital for foot care, but many clinicians do not have an understanding of the possibilities and the constraints that exist.  Also in many countries, educational programmes for prescription shoemakers don’t exist now.  Competent craftsmen can be difficult to find. 

Prescription footwear is often classified as "stock", "modular" or "bespoke". This places attention on the shoe rather than where it should be - on the patient’s requirements.

As approaches to risk stratification emerge, we have a great opportunity to change how shoes are specified and provided.  We can take advantage of technology and shoe “know-how” to make available a new type of High St shoes that have all the qualities to protect the feet of low to moderate risk patients.

We know that users of all prescription shoes still want to be delighted by what they receive but It’s been difficult to reconcile these factors in the past. Advances in technology certainly permit this now - especially for patients with lower risk.

For the High Street we have always mass-produced footwear for the consumer.  Prescription footwear was different. To now apply technology to prescription footwear is a challenge. It means meeting individual needs but with economies of mass production.

By using a range of technologies we can guide anyone through the processes to supply these shoes.  We can ensure that foot shape measurements are accurate and we can verify that last selection, materials choices and so on are consistent and appropriate. By using computer based methods we also have ideal tools for learning and continual improvement.